The University of Wisconsin School of Medicine and Public Health welcomes opportunities to participate in research financially supported by industry. These opportunities arise when a UW School of Medicine and Public Health investigator and an industry partner identify a research area of mutual interest, which could include:
- Laboratory research
- Research involving human subjects (note that clinical trials are a special class of human subjects research that are handled separately)
- Nonlaboratory-based scholarly activity
Such research benefits the University of Wisconsin School of Medicine and Public Health by allowing academic investigators and their students to gain insight into industry problems and access funding for their research, and industry benefits by accessing the basic science competency and laboratory resources that it typically cannot afford to maintain internally.
The challenge is to identify a mutually acceptable set of terms controlling how the research will be conducted, bridging the gap between academia’s mission (educating students and creating and disseminating new knowledge) and private sector drivers (making a profit and gaining a competitive edge over others). These terms are negotiated and recorded in a legal contract called a sponsored research agreement (SRA).
Negotiating SMPH Sponsored Research Agreements
The University of Wisconsin School of Medicine and Public Health maintains a standard sponsored research agreement that can be used for most projects. Any changes to the agreement or any agreement proposed by the sponsor requires review and, typically, negotiation.
Sponsored research agreements contain legally binding terms that dictate each party’s rights and obligations with respect to publication, access to data and results, rights to intellectual property arising from the research and many other areas.
These issues are often challenging to reach agreement on due to the university’s and the industry sponsor’s divergent goals for the use of the results of the research, and the legal risks each party is willing to accept to conduct the research. These issues are discussed in more detail below. In many cases, detailed analysis of legal language may be required, and input from multiple offices within both the university and the company may be needed.
Budgeting Sponsored Research Agreements
Sponsored research can be conducted as either a fixed price activity, in which a price is set for which the entire scope of work will be completed, or a cost reimbursable activity, in which the industry sponsor is invoiced for actual costs as they are incurred.
The fixed price approach is much more common, and budgets are built as they would be for federally sponsored research. Indirect costs are always included at the federally approved indirect cost rate, since indirect costs represent the true costs to the university for performing the work, and the university does not subsidize research for private companies by paying indirect costs itself.
How Long Will This Take?
The university’s standard sponsored research agreement can be executed within two weeks, once the sponsor and investigator agree upon a scope of work and budget. Negotiating changes to the standard sponsored research agreement or review and negotiation of a sponsor’s agreement may take from one to six months or longer, depending upon the degree of divergence in initial positions.
Hence, the overall timeline for placing a sponsored research project may be similar to that for applying for a grant: The reduction in time related to grant review for a National Institutes of Health (NIH) proposal is often offset by time needed for the university and the company to define a mutually acceptable working relationship.
Procedures for Establishing Sponsored Research Agreements
1. Establish the scope of work and cost
The investigator works with the company to agree upon a scope of work. The investigator then builds a budget for this workscope, applying the same budgeting principles as are used for federal grant proposals. The company is typically expected to fund the full cost of the project. The company always pays the full indirect costs at the current federal rate, which are true costs allocated across all projects, and which pay for maintenance of the university research infrastructure.
Department administrators will assist with budget development, and the Office of Industry Engagement (OIE) offers a spreadsheet that assists in calculating costs. Upon request, OIE will review these budgets before they are presented to a sponsor, and this step can save the need to present a modified budget to the sponsor if OIE finds changes that need to be made upon later review.
2. Identify the sponsored research agreement to be used
Contact the Office of Industry Engagement for the correct standard agreement to propose to the sponsor. Use of the standard university sponsored research agreement is the key to rapid initiation of industry sponsored research. If the sponsor insists that their agreement be used, obtain a copy, preferably as a Microsoft Word document. Sponsor agreements require review and, in most cases, negotiation.
3. Prepare the WISPER record
The principal investigator (PI) and/or staff, with the help of departmental administration as needed, completes the WISPER record. Questions regarding this procedure should be directed to departmental administrators, who are familiar with WISPER. Note especially the following items in WISPER that need to be completed before OIE’s review of a sponsored research agreement:
- If the project requires biohazard approval or involves human subjects, list the protocol numbers for the approval covering this project. If the project involves vertebrate animals, please upload the approval letter received from Research Animal Resources Center (RARC) to the WISPER record. If these are pending, note this in the WISPER record – while we can continue to process the agreement, the project cannot begin until the approvals are in place.
- If the agreement is to be sent to the sponsor by overnight delivery, scan and upload the shipping label. There is no need to send an envelope through the system.
- Under the Comments tab, provide the name, e-mail address and/or phone number for the person at the providing institution/company to whom questions about the contract language should be addressed. Also, any background information on the history of the request, such as e-mails, may be inserted, and can be useful for negotiations.
- Under Submission Instructions, provide the full name and address to which the signed sponsored research agreement should be sent. If there are other submission instructions, make sure you include them here, including the number of signed copies of the SRA that need to be sent to the sponsor.
- Upload the proposed sponsored research agreement to the WISPER record under the attachments tab.
- Complete the Projects Tab in WISPER. This section must be completed before the Office of Industry Engagement will submit the WISPER record to the Office of Industrial Partnerships (OIP). A detailed description of how to complete this section can be found on pages 46-55 of the RSP WISPER manual. After completing the Projects Tab, make sure you scroll to the bottom of the page and click on the yellow button marked “Validate to Req Project/Award Finalized of SPO” and make sure that there are no errors. Ignore the following error messages: “Division has not Signed this Proposal,” “Division has not Signed this Award” and “The Sponsor on this record is not currently recognized. Please contact your Sponsored Projects Office with the record ID to proceed.”
- Effort: A minimum of 1 percent effort for the principal investigator must be included.
- Fringe Benefit Rates: Make sure you are using the most current fringe benefit rates for staff in the SRA budget. Use the link above to see the most current rates.
- Facilities and Administration Rate (F&A, Indirect Costs): Industry sponsors are always charged the full federal indirect rate (either on campus or off campus, as appropriate).
4. Prepare the sponsored research agreement for submission
- The sponsored research agreement should be read by the principal investigator, and any concerns noted in the Comments section of the WISPER record.
- All blanks in the sponsored research agreement should be filled in before routing the record to SMPH, except a space left for insertion of the date of execution, typically in the first paragraph, and the spaces for institutional signature and identification of the institutional signatory.
- The sponsored research agreement should list, as the recipient, the “Board of Regents of the University of Wisconsin System on behalf of the University of Wisconsin-Madison,” and if a business address is required, normally in the opening paragraph, it should be “21 N. Park St., Suite 6401, Madison, Wisconsin 53715.” Do not list the name and address of the principal investigator, department, or UW School of Medicine and Public Health as the recipient party.
- If the sponsored research agreement requires that the principal investigator be named, the person should be a faculty member with a tenure-track, CHS or Clinical appointment, or a UW investigator with permanent or temporary principal investigator status. Do not list graduate students, post-docs, etc. If an individual without principal investigator status is named in the agreement, the agreement will be returned for revision.
- The principal investigator should only sign the sponsored research agreement if there is a blank labeled specifically as a PI signature line. The PI should not sign in a space intended for the institutional signature.
5. Send approval request for WISPER record to the chair for sign-off
Then route to SMPH for OIE review.
6. Route paper copies
If a PI signature on the SRA is required, send two paper copies of the SRA, each with an original signature, to Andy Chen at OIE.
7. Sponsored research agreement processing by the Office of Industry Engagement and Research and Sponsored Programs
- The Office of Industry Engagement will review the WISPER record for completeness, and route the record back to the listed departmental contact if all the required information is not filled in, or if additions or corrections are needed. Note that this adds effort and delays the process, so it is important for the WISPER record to be complete upon initial routing.
- Once the WISPER record is complete, the Office of Industry Engagement will review the sponsored research agreement itself. If it is a standard university agreement, it can be sent by OIE to OIP for signature without further action by OIE. If not, OIE will review the SRA for consistency with University policy, and OIP will negotiate changes with the provider where needed.
- Once the terms and conditions in the SRA conform to university policy, OIP will sign and the principal investigator and departmental contact will be notified when this occurs.
- The Office of Industry Engagement will route the WISPER record to OIP, where they will perform a final review of all documents and sections of WISPER. OIP will then send the agreement to the sponsor based upon the original submission method listed. After receiving a fully executed agreement from the sponsor, OIP will upload a scanned version to WISPER, and change the record status to 6-Completed. The principal investigator, department contact and OIE will receive a WISPER notification of this status change. The PI can now obtain the requested materials or begin the research project.